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RECRUITING
NCT07246044
NA

HD-tDCS for Adolescent Bipolar Depression Targeting S1

Sponsor: Jiangsu Province Nanjing Brain Hospital

View on ClinicalTrials.gov

Summary

This randomized, double-blind, sham-controlled clinical trial aims to evaluate the efficacy and underlying biological mechanisms of HD-tDCS targeting the primary somatosensory cortex in adolescents with bipolar depression. Participants will be randomly assigned to receive either active HD-tDCS or sham stimulation, in addition to routine clinical care. Biological data, including neuroimaging, blood biomarkers, voice and facial features, Photoplethysmography (PPG), Electroencephalography (EEG), and behavioral data, will be collected to explore potential predictors of treatment response.

Official title: High-Definition Transcranial Direct Current Stimulation (HD-tDCS) Targeting the Primary Somatosensory Cortex for Bipolar Depression in Adolescents: A Randomized Double-Blind Controlled Trial

Key Details

Gender

All

Age Range

12 Years - 18 Years

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2025-09-16

Completion Date

2027-12-31

Last Updated

2025-11-24

Healthy Volunteers

No

Interventions

DEVICE

Active HD-tDCS

HD-tDCS is a non-invasive neuromodulation therapy which has been recognized as a helpful treatment for depression. During each HD-tDCS treatment, the electrode field is generated by a 4\*1 ring montage which is placed over the scalp on the brain region of interest with an electrical current induced to modulate brain activity.

DRUG

Antipsychotics, mood stabilizers, etc.

During the HD-tDCS treatment period, all the participants will maintain the stable medication regimen according to clinical practice guidelines.

DEVICE

Sham HD-tDCS

Sham HD-tDCS is administered using the same electrode configuration as the active HD-tDCS condition. During each session, the device ramps up current briefly (typically 30 seconds) to mimic the initial sensation of stimulation, then remains off for the remainder of the 20-minute session. This method produces the same tactile perception as active stimulation without delivering a therapeutic dose of current.

Locations (1)

Affiliated Nanjing Brain Hospital, Nanjing Medical University

Nanjing, Jiangsu, China